This application is a 371 of PCT/US99/08507 filed April 23, 1999 which claims the benefit of U.S. Provisional Application No. 60/126,419 filed April 23, 1998.
This invention relates to catheter connectors and methods for connection generally, and more specifically to catheter connectors and methods for portal assemblies.
The treatment of certain diseases of the human body or an animal""s body often requires infusion of drugs, blood products, nutritional fluids, or other fluids into the patient""s venous or arterial system, the patient""s peritoneal or epidural space, or other locations within the patient""s body. One system which is useful when repeated access for infusion is needed utilizes an implanted portal assembly which is accessed percutaneously to infuse the fluid to the desired location. A similar arrangement can be used to draw blood from an artery or vein for blood sampling purposes, or to draw other body fluids.
Such an implanted assembly includes a port which is implanted under the skin and attached to the chest wall or other convenient body location. The port includes a septum for accessing an interior of the port. The septum is located directly under the skin and is penetrable by a needle. Drugs or other fluids can be introduced into the port (or fluids withdrawn from the port) by percutaneously inserting the needle through the septum of the port. The port includes an outlet member which is connected via connection structure to one end of a flexible elastic catheter which leads to the infusion (or withdrawal) site in the patient""s body.
U.S. Pat. No. 4,880,414 issued Nov. 14, 1989, and U.S. Pat. No. 4,723,948 issued Feb. 9, 1988 are two examples of different connection structure for connecting a catheter to a port.
Such an implantable port device of this type may remain in the patient""s body for a long period of time, such as several months. A significant concern is that the connection between the catheter and the port remain secure and fluid tight during the period of implantation. The catheter and port may be subjected to various external forces acting to separate the catheter from the port. Should the connection fail, the fluids injected into the port would not be transported to the targeted infusion site and instead the fluid would be dispensed at the site of the port. This can be a particular concern in the case of certain drug therapies, such as chemotherapy, in which the drugs are highly concentrated and dangerous if misdirected in the patient""s body. Withdrawal of fluids would also be adversely affected if the connection failed.
A further concern is the ease and reliability in which the port can be connected to the catheter. Typically, the connection between the port and the catheter is made during the implantation surgery when the portal assembly is first installed. A surgeon handling the implantation surgery will be wearing gloves, and the gloves or port may be covered with body fluids from the surgery. There is a need for the connector structure to be easy to use in these circumstances and to do so reliably. There is also a need for the connection to be made quickly to keep the length of the surgery as short as possible.
Another concern with respect to implantable devices of this type is that it may be necessary to disconnect the catheter from the port after implantation if the catheter or port needs to be changed. One concern is whether the connection between the catheter and port is easily disconnectable.
A further concern is the size of the catheter connector. A connector that is too bulky can be a problem for the patient. Intricate parts can be a problem for manufacture of the connector, and also use of the connector, especially if the parts are small in size.
U.S. Pat. No. 5,562,618 issued Oct. 8, 1996 is a further example of connection structure for connecting a catheter to a port. Specifically, the ""618 patent shows a connector 26 for use in connecting a dual lumen catheter 24 to a port having two different needle access sites 48 and two outlet tubes 34, 36. A sleeve 102 and a lock ring 120 connect catheter 24 to outlet tubes 34, 36. Connector 26 of the ""618 patent bunches up an end of catheter 24 during use as shown in FIG. 6.
There continues to be a need in the art for catheter connectors and connection methods generally, and more specifically catheter connectors and methods for connecting catheters to ports which address at least some of the above concerns and other concerns in the art. There is a particular need for connectors and methods for sealing a multi-lumen catheter having at least two lumens to multiple outlet tubes.